Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial

Hypertension Clinical Trial

— ReSET  

Official title:

Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459900
• Other study ID #: M-20110071
• Status: Completed
• Phase: N/A
• First received: October 24, 2011
• Last updated: September 19, 2016
• Start date: September 2011
• Est. completion date: February 2015

Study information

• Verified date: September 2016
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this double blind, randomized and sham controlled study is to determine whether renal denervation in terms of catheter based ablation in the renal arteries is effective in lowering blood pressure in patients with treatment resistant hypertension. The blood pressure lowering effect will be evaluated by 24 hours ambulatory blood pressure measurement at baseline and after 1, 3 and 6 months of follow up. Secondary end point evaluation concerns hemodynamic measures using echocardiography, applanation tonometry and forearm plethysmography.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Systolic daytime ambulatory BP at least 145 mmHg and compliance to a minimum of 3 antihypertensive drugs, including a diuretic, or in case of diuretic intolerance at least 3 nondiuretic antihypertensive drugs.

Exclusion Criteria:

• Pregnancy

• Non compliance

• Heart Failure (NYHA 3-4)

• LV ejection fraction < 50 %

• Renal insufficiency (eGFR<30)

• Unstable coronary heart disease

• Coronary intervention within 6 months

• Myocardial infarction within 6 months

• Claudication

• Orthostatic syncope within 6 months

• Secondary Hypertension

• Permanent atrial fibrillation

• Significant Heart Valve Disease

• Clinically Significant abnormal electrolytes, haemoglobin, Liver enzymes, TSH

• Second and third degree heart block

• Macroscopic haematuria

• Proximal significant coronary stenosis

• Renal artery anatomy not suitable for renal artery ablation (Stenosis, small diameter < 4 mm, length < 2 cm, multiple renal arteries, severe calcifications)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Procedure:
• Renal artery ablation
Catheter based renal denervation by applying low power radiofrequency to the renal artery using the Ardian Medtronic Simplicity Catheter, introduced by femoral artery access.
• Renal angiography
Renal angiography by femoral access.

Locations

Country	Name	City	State
Denmark	Skejby Hospital	Aarhus	Aarhus N

Sponsors (6)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Aarhus University Hospital, Central Jutland Regional Hospital, Randers Regional Hospital, Regional Hospital Holstebro, Regionshospitalet Silkeborg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	daytime systolic blood pressure assessed by 24 hours ambulatory BP measurement	Changes in mean daytime systolic BP after 3 months is compared between groups. Also the proportion of responders versus nonresponders after 3 months is compared between groups, responders being defined as A) a minimum decrease in daytime systolic BP of 10 mmHg analysis together with and unchanged/increased number of antihypertensive drugs, or B) a decrease in daytime systolic BP of 0-10 mmHg together with a reduced number of antihypertensive drugs.	3 months follow up	No
Secondary	ambulatory 24 hours BP measurements	Systolic, diastolic and mean Blood Pressures at different time points. Daytime and night time BP, dipping status, morning BP surge and BP variation.	1, 3 and 6 months	No
Secondary	Echocardiography	Coronary flow reserve (LAD), Diastolic and Systolic ventricular function. LV hypertrophy.	6 months	No
Secondary	Biomarkers	Biomarkers concerning renal sodium excretion	1 months	No
Secondary	Applanation tonometry	Pulse wave velocity, augmentation index, central BP estimates	6 months	No
Secondary	forearm plethysmography	Forearm minimum vascular resistance	6 months	No